Novel Drug Delivery Systems Approved by USFDA from 2019 to 2023: A Comprehensive Review.

In recent years, tremendous progress in the field of novel drug delivery systems (NDDS), which has prompted the creation of new strategies to enhance treatment results and patient compliance. The goal of this comprehensive review is to provide a summary of the NDDS that the US Food and Drug Administration (USFDA) has approved from 2019 to 2023. Various databases, including PubMed, Scopus, USFDA, and patent websites were utilized to gather relevant information.

Nanoemulsion-based polyherbal mouthwash of cinnamon and clove oil: physicochemical characterization, molecular docking, and antimicrobial evaluations.

Objective: Different oils were used to develop nanoemulsion-based polyherbal mouthwashes (PHMs) of hydroalcoholic extract, and then their antibacterial activities against a range of oral pathogenic bacteria were assessed. Standard chlorhexidine acetate (CHD-A) was used as a control.

Methods: Different PHMs of extract based on nanoemulsions were obtained and the influence of various oils such as clove oil (CO), eucalyptus oil (EO), rose oil (RO), peanut oil (PO), and sesame oil (SO) on physicochemical and antibacterial characteristics of PHMs was studied.

Utilization of Waste Eggshell Powder as an Excipient for Vitamin D3 Tablet Preparation.

Keeping in mind the health scenario in Kingdom of Saudi Arabia with respect to vitamin D3 (VD3) deficiency and its significant role in calcium homeostasis and human metabolism, this research is exploring the combination of eggshell (as a source of calcium) and VD3 as a very economical solution for this problem. Eggshells from local restaurant were collected, washed, ground, sieved, and characterized by Fourier transforms infrared spectroscopy (FTIR), scanning electron microscopy (SEM), differential scanning calorimetry (DSC), X-ray diffraction (XRD), and Brunauer-Emmett-Teller (BET) techniques. The results of FTIR, SEM, DSC, XRD, and BET indicate that eggshell powder (ESP) was properly processed.

Solubility and Thermodynamics Data of Cabozantinib Malate in Various Aqueous Solutions of Dimethyl Sulfoxide at Different Temperatures.

Cabozantinib malate (CBZM), a new anticancer medication, has been studied for its solubility and thermodynamic properties in a variety of {dimethyl sulfoxide (DMSO) + water (HO)} mixtures at 298.2-318.2 K and 101.

Evaluation of the Physicochemical and Antimicrobial Properties of Nanoemulsion-Based Polyherbal Mouthwash.

A nanoemulsion-based polyherbal mouthwash (PHFX) of hydroalcoholic extract was developed and evaluated for its antibacterial effects against a variety of Gram-positive and Gram-negative oral pathogens in comparison to standard chlorhexidine acetate (CHD-A) (positive control). Various nanoemulsion-based mouthwashes of extract were produced using an aqueous phase titration approach via construction of pseudoternary phase diagrams. The developed nanoemulsion-based PHFX was studied for thermodynamic stability tests.

Solubility and Thermodynamic Analysis of Isotretinoin in Different (DMSO + Water) Mixtures.

The solubility and solution thermodynamics of isotretinoin (ITN) (3) in numerous {dimethyl sulfoxide (DMSO) (1) + water (HO) (2)} combinations were studied at 298.2-318.2 K under fixed atmospheric pressure of 101.

Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples.

In this study, an environmentally friendly "high-performance liquid chromatography (HPLC)" assay to quantify isotretinoin (ITN) in commercial products and solubility samples is designed and verified. A Nucleodur reverse-phase C column was used as the stationary phase to identify ITN. The ecologically friendly mobile phase was composed of ethyl acetate and ethanol (50:50 v/v), and it was delivered at a flow rate of 1.

Erlotinib-Loaded Dendrimer Nanocomposites as a Targeted Lung Cancer Chemotherapy.

Lung cancer is the main cause of cancer-related mortality globally. Erlotinib is a tyrosine kinase inhibitor, affecting both cancerous cell proliferation and survival. The emergence of oncological nanotechnology has provided a novel drug delivery system for erlotinib.

Chitosan loaded RNA polymerase inhibitor nanoparticles increased attenuation in toxin release from .

Background: Multidrug-resistant (MDR) bacterial infections have become an emerging health concern around the world. Antibiotics resistance among  strains increased recently contributing to increase in incidence of pneumococcal infection. This necessitates the discovery of novel antipnemococcal such as compound C3-005 which target the interaction between RNA polymerase and σ factors.

Solubilization and Thermodynamic Analysis of Isotretinoin in Eleven Different Green Solvents at Different Temperatures.

The solubilization and thermodynamic analysis of isotretinoin (ITN) in eleven distinct green solvents, such as water, methyl alcohol (MeOH), ethyl alcohol (EtOH), 1-butyl alcohol (1-BuOH), 2-butyl alcohol (2-BuOH), ethane-1,2-diol (EG), propane-1,2-diol (PG), polyethylene glycol-400 (PEG-400), ethyl acetate (EA), Transcutol-HP (THP), and dimethyl sulfoxide (DMSO) was studied at several temperatures and a fixed atmospheric pressure. The equilibrium approach was used to measure the solubility of ITN, and the Apelblat, van’t Hoff, and Buchowski−Ksiazczak λh models were used to correlate the results. The overall uncertainties were less than 5.

Attenuation of Quorum Sensing Virulence of Biofilm and Pyocyanin by mBTL-Loaded Calcium Alginate Nanoparticles.

contributes to many chronic infections and has been found to be resistant to multiple antibiotics. Pseudomonas use a quorum sensing system (QS) to control biofilm establishment and virulence factors, and, thus, quorum sensing inhibitors (QSIs), such as meta-bromo-thiolactone (mBTL), are promising anti-infective agents. Accordingly, this study intended to investigate the antibacterial and anti-virulence activity of mBTL-loaded calcium alginate nanoparticles (CANPs) against and different QS mutants.

Retinal Delivery of the Protein Kinase C-β Inhibitor Ruboxistaurin Using Non-Invasive Nanoparticles of Polyamidoamine Dendrimers.

Ruboxistaurin (RBX) is an anti-vascular endothelial growth factor (anti-VEGF) agent that is used in the treatment of diabetic retinopathy and is mainly given intravitreally. To provide a safe and effective method for RBX administration, this study was designed to develop RBX nanoparticles using polyamidoamine (PAMAM) dendrimer generation 5 for the treatment of diabetic retinopathy. Drug loading efficiency, and in vitro release of proposed complexes of RBX: PAMAM dendrimers were determined and the complexation ratio that showed the highest possible loading efficiency was selected.

Development and Optimization of Ciprofloxacin HCl-Loaded Chitosan Nanoparticles Using Box-Behnken Experimental Design.

Various chitosan (CS)-based nanoparticles (CS-NPs) of ciprofloxacin hydrochloride (CHCl) have been investigated for therapeutic delivery and to enhance antimicrobial efficacy. However, the Box-Behnken design (BBD)-supported statistical optimization of NPs of CHCl has not been performed in the literature. As a result, the goal of this study was to look into the key interactions and quadratic impacts of formulation variables on the performance of CHCl-CS-NPs in a systematic way.

Self-Nanoemulsifying Drug Delivery System (SNEDDS) of Apremilast: In Vitro Evaluation and Pharmacokinetics Studies.

Psoriatic arthritis is an autoimmune disease of the joints that can lead to persistent inflammation, irreversible joint damage and disability. The current treatments are of limited efficacy and inconvenient. Apremilast (APR) immediate release tablets Otezla have 20-33% bioavailability compared to the APR absolute bioavailability of 73%.

Hepatoprotective Effects of Bioflavonoid Luteolin Using Self-Nanoemulsifying Drug Delivery System.

Luteolin (LUT) is a natural pharmaceutical compound that is weakly water soluble and has low bioavailability when taken orally. As a result, the goal of this research was to create self-nanoemulsifying drug delivery systems (SNEDDS) for LUT in an attempt to improve its in vitro dissolution and hepatoprotective effects, resulting in increased oral bioavailability. Using the aqueous phase titration approach and the creation of pseudo-ternary phase diagrams with Capryol-PGMC (oil phase), Tween-80 (surfactant), and Transcutol-HP (co-emulsifier), various SNEDDS of LUT were generated.

Solubilization, Hansen solubility parameters, and thermodynamic studies of delafloxacin in (transcutol + 1-butyl-3-methyl imidazolium hexafluorophosphate) mixtures.

The solubilization, Hansen solubility parameters (HSPs), and thermodynamic properties of delafloxacin (DLN) in various unique combination of Transcutol-HP® (THP) and 1-butyl-3-methyl imidazolium hexafluorophosphate ionic liquid (BMIM-PF) mixtures were evaluated for the first time in this research. The 'mole fraction solubilities ()' of DLN in different (THP + BMIM-PF) compositions were determined at ' = 298.2-318.

Properties of Ethnomedicinal Plants and Their Bioactive Compounds: Possible Use for COVID-19 Prevention and Treatment.

Background: The coronavirus disease 2019 (COVID-19) pandemic has changed the global scenario. To date, there are no treatment or preventive options. The discovery of a new drug will take time.

Solubility, Hansen Solubility Parameters and Thermodynamic Behavior of Emtricitabine in Various (Polyethylene Glycol-400 + Water) Mixtures: Computational Modeling and Thermodynamics.

This study was aimed to find out the solubility, thermodynamic behavior, Hansen solubility parameters and molecular interactions of an antiviral drug emtricitabine (ECT) in various "[polyethylene glycol-400 (PEG-400) + water]" mixtures. The solubility of ECT in mole fraction was determined at " = 298.2 to 318.

Colored Polymeric Nanofiber Loaded with Minoxidil Sulphate as Beauty Coverage and Restoring Hair Loss.

Polymeric nanofibers fabricated by electrospinning either blank (PVA) or loaded with minoxidil sulphate have yielded optimum fibers with an average diameter 273 nm, and 511 nm, respectively. Thermal analysis of nanofibers indicated no chemical interaction. The NMR spectrum confirmed stability of nanofiber as there were no interactions between functional groups.

Solubility Measurement and Various Solubility Parameters of Glipizide in Different Neat Solvents.

Glipizide (GLZ) is an oral hypoglycemic agent, which is a weakly aqueous soluble drug. The solubility values of GLZ in various neat solvents are scarce in the literature. Hence, the solubility of GLZ in 12 different neat solvents, namely, "water, methanol, ethanol, isopropanol (IPA), 1-butanol, 2-butanol, ethylene glycol (EG), propylene glycol (PG), poly(ethylene glycol)-400 (PEG-400), ethyl acetate (EA), dimethyl sulfoxide (DMSO), and Transcutol-HP (THP)", at " = 298.

Physical PEGylation Enhances The Cytotoxicity Of 5-Fluorouracil-Loaded PLGA And PCL Nanoparticles.

Purpose: The main goal of this study is to evaluate the impact of physical incorporation of polyethylene glycol (PEG) into 5-fluorouracil (5-FU)-loaded polymeric nanoparticles (NPs).

Methods: The 5-FU-loaded NPs were prepared utilizing a simple double emulsion method using polycaprolactone (PCL) and polylactic-co-glycolic acid (PLGA) with or without PEG 6000. The surface charge, particle size, and shape of NPs were evaluated by standard procedures.

Chemical composition and antimicrobial, antioxidant, and anti-inflammatory activities of seed oil.

(garden cress) seed oil was examined for its antimicrobial, antioxidant, and anti-inflammatory activities. The oil was obtained by hydrodistillation, where gas chromatography coupled with mass spectrometry that utilized to study its chemical composition. Microdilution method was used to test the antimicrobial effect of oil against , , , , , , and .

Nasal delivery of donepezil HCl-loaded hydrogels for the treatment of Alzheimer's disease.

This study aims to prepare, characterize and evaluate the pharmacokinetics of liposomal donepezil HCl (LDH) dispersed into thiolated chitosan hydrogel (TCH) in rabbits. Various hydrogels including TCH were prepared, and after characterization, TCH was selected for subsequent evaluations, due to the promising results. TCH was then incorporated with LDH prepared by reverse phase evaporation method.

Solidified SNEDDS for the oral delivery of rifampicin: Evaluation, proof of concept, in vivo kinetics, and in silico GastroPlus simulation.

The present investigation was performed to develop a rifampicin (RIF)-loaded solidified self-nanoemulsifying drug delivery system (SNEDDS) (solidified RIF-OF1) for in vitro and in vivo evaluations. Optimized formulations were tested for their powder flow characteristics, loading efficiency, and in vitro dissolution (at pH-1.2, 6.

Wound healing evaluation of self-nanoemulsifying drug delivery system containing essential oil.

The objective of this work was to characterize and evaluate wound healing potential of oil (PO) via self-nanoemulsifying drug delivery system (SNEDDS) in comparison with standard gentamycin. PO loaded SNEDDS was prepared by low energy emulsification technique and characterized for thermodynamic stability, self-emulsification power and various physico-chemical parameters. An optimal formula of PO SNEDDS was subjected to wound healing evaluation, collagen determination and histomorphological examination in female Wistar rats as compared with pure PO and standard antibiotic/gentamycin.